PBT Assessment - REACh

Guidance on information 

requirements and chemical safety 

assessment 

Part C: PBT Assessment 

May 2008 

Guidance for the implementation of REACH

2 

LEGAL NOTICE 

This document contains guidance on REACH explaining the REACH obligations and how 

to fulfil them. However, users are reminded that the text of the REACH regulation is the 

only authentic legal reference and that the information in this document does not 

constitute legal advice. The European Chemicals Agency does not accept any liability with 

regard to the contents of this document. 

© European Chemicals Agency, 2008 

Reproduction is authorised provided the source is acknowledged.

PREFACE 

PART C – PBT ASSESSMENT 

This document describes the information requirements under REACH with regard to substance 

properties, exposure, use and risk management measures, and the chemical safety assessment. It is 

part of a series of guidance documents that are aimed to help all stakeholders with their preparation 

for fulfilling their obligations under the REACH regulation. These documents cover detailed 

guidance for a range of essential REACH processes as well as for some specific scientific and/or 

technical methods that industry or authorities need to make use of under REACH. 

The guidance documents were drafted and discussed within the REACH Implementation Projects 

(RIPs) led by the European Commission services, involving stakeholders from Member States, 

industry and non-governmental organisations. These guidance documents can be obtained via the 

website of the European Chemicals Agency (http://echa.europa.eu/about/reach_en.asp). Further 

guidance documents will be published on this website when they are finalised or updated. 

This document relates to the REACH Regulation (EC) No 1907/2006 of the European Parliament 

and of the Council of 18 December 2006 1 

1 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 

concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European 

Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and 

Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 

91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006); amended by Council Regulation (EC) 

No 1354/2007 of 15 November 2007 adapting Regulation (EC) No 1907/2006 of the European Parliament and of the 

Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) by reason of the 

accession of Bulgaria and Romania (OJ L 304, 22.11.2007, p. 1). 

3


Convention for citing the REACH regulation 

Where the REACH regulation is cited literally, this is indicated by text in italics between quotes. 

Table of Terms and Abbreviations 

See Chapter R.20 

Pathfinder 

The figure below indicates the location of part C within the Guidance Document. 

4

CONTENTS 


C.1 PBT AND VPVB ASSESSMENT ............................................................................... 7 

C.1.1 Aim and procedure ............................................................................................................................................. 7 

C.1.2 PBT and vPvB criteria ....................................................................................................................................... 7 

C.1.3 Comparison with the PBT and vPvB criteria .................................................................................................. 8 

C.1.4 Test strategies ................................................................................................................................................... 11 

C.1.4.1 Persistency ................................................................................................................................................ 11 

C.1.4.2 Bioaccumulation ....................................................................................................................................... 12 

C.1.4.3 Toxicity ..................................................................................................................................................... 13 

C.1.5 Conclusions on PBT or vPvB properties ........................................................................................................ 14 

C.1.6 Further actions if a substance is identified as a PBT or a vPvB ................................................................... 14 

TABLES 

Table C.1-1: PBT and vPvB criteria according to Annex XIII of the REACH Regulation ................................................ 9 

Table C.1-2: Screening criteria for Persistency, Bioaccumulation, and Toxicity ............................................................. 10 

5

C.1 PBT AND VPVB ASSESSMENT 


A PBT/vPvB assessment is required for all substances for which a chemical safety assessment 

(CSA) must be conducted. These are in general all substances manufactured or imported in 

amounts of 10 or more tonnes per year that are not exempted from registration under REACH. 

However, some further exemptions apply, e.g. substances present in a preparation if the 

concentration is less than 0.1 % weight by weight (Article 14(2)), for on-site isolated (Art. 17) 

or transported intermediates (Art. 18), and for Product and Process Oriented Research and 

Development (Art. 9) (see Guidance on Registration, Section 1.8.1, for further information). 

C.1.1 Aim and procedure 

The objective of the PBT/vPvB assessment is to determine in a stepwise procedure: 

1. Whether the substance fulfils the criteria given in Annex XIII (comparision with the 

criteria) . 

If it is concluded that the substance is not a PBT/vPvB substance, the PBT/vPvB 

assessment stops after comparison with the criteria. An exposure and risk assessment as 

for a non-PBT/vPvB substance could however be required if the substances is dangerous 

in accordance with the classification criteria of Council Directive 67/548/EEC. 

2. If a substance is confirmed to be a PBT/vPvB substance, the registrant needs in a second 

step (emission characterisation; see Sections C.1.6 and R.11.2 for further guidance) to 

estimate the amounts of the substance released to the different environmental 

compartments during all activities carried out by the registrant and all identified uses. In 

addition, it is necessary to identify the likely routes by which humans and the environment 

are exposed to the substance. 

3. The registrant shall use the information obtained during the emission characterisation 

step, for implementing on his site, and recommending to downstream users, risk 

management measures (RMM) which minimise emissions and subsequent exposures of 

humans and the environment throughout the lifecycle of the substance that results from 

manufacture or identified uses. 

C.1.2 PBT and vPvB criteria 

A substance that fulfils all three of the criteria for persistence, bioaccumulation and toxicity 

described in Table C.1-1 is a PBT substance. 

It should however be noted that, even where a criterion is marginally not fulfilled, the overall 

evidence can be sufficient to justify the conclusion that a substance fulfils the Annex XIII 

criteria. This includes for example substances that do not fulfil the persistence criteria but 

bioaccumulate significantly and are measured in increasing levels over time in biota distant 

from anthropogenic sources (see Section R.11.1.5 for further guidance). 

7


C.1.3 Comparison with the PBT and vPvB criteria 

The PBT and vPvB assessment of a substance shall be based on all the relevant information 

available, which is normally the information that shall be submitted as part of the technical 

dossier, including the physicochemical, hazard and exposure information generated in the 

context of the CSA. If the technical dossier, for one or more endpoints, contains only the 

information as required in Annexes VII and VIII, the registrant shall, based on screening 

criteria or other information available, consider whether further information needs to be 

generated to fulfil the objective of the PBT and vPvB assessment, i.e. to assess whether the 

substance fulfils the criteria. Hence, it is task of the registrant to assess if the information that 

is available and/or produced is sufficient to conclude whether the substance is a PBT or a 

vPvB substance or not. In many cases further information as detailed in Annexes IX and X of 

the Regulation may need to be generated before it can be judged whether the substance fulfils 

the Annex XIII criteria. Generally, before generating information detailed in Annexes IX and 

X, a testing proposal needs to be submitted to and authorised by the ECHA. 

The PBT assessment is initiated by an evaluation of all available information. For substances 

below a volume of 100 t/y normally data on ready biodegradability, octanol-water partitioning 

coefficient (log Kow) and environmental toxicity are available that give an indication on the 

P, B and T properties of a substance. 

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Table C.1-2 gives an overview of information that can be used for a screening assessment and 

provides criteria to decide whether an in depth assessment on the PBT or vPvB properties is 

necessary. 

When the screening criteria do not clearly indicate that there is no concern that the substance 

could meet the Annex XIII criteria (Table C.1-1), a stepwise approach is followed for the 

definitive assessment of the P, B and T criteria, which is further outlined below. 

Table C.1-1: PBT and vPvB criteria according to Annex XIII of the REACH 

Regulation 

Property PBT-criteria vPvB-criteria 

Persistence 1 

Bioaccumulation 2 

- T1/2 > 60 days in marine water, or 

- T1/2 > 40 days in fresh- or estuarine water, or 

- T1/2 > 180 days in marine sediment, or 

- T1/2 > 120 days in fresh- or estuarine sediment, 

or 

- T1/2 > 120 days in soil. 

- T1/2 > 60 days in marine, 

fresh- or estuarine water, 

or 

- T1/2 > 180 days in 

marine, fresh- or 

estuarine sediment, or 

- T1/2 > 180 days in soil. 

BCF > 2000 L/kg BCF > 5000 L/kg 

Toxicity - NOEC < 0.01 mg/L for marine or freshwater 

organisms, or 

Screening assessment 

- substance is classified as carcinogenic 

(category 1 or 2), mutagenic (category 1 or 2), 

or toxic for reproduction (category 1, 2 or 3), 

or 

- there is other evidence of chronic toxicity, as 

identified by the classifications: T, R48, or 

Xn, R48 according to Directive 67/548/EEC. 

The screening criteria (Table C.1-2) should always be considered in conjunction for P, B and 

T to decide whether the substance has to be regarded as a potential PBT/vPvB. It has to be 

kept in mind that the fact that a substance does not meet the T criterion is not enough to stop 

the evaluation of the remaining endpoints in the PBT/vPvB screening step. Similarly, 

conflicting evidence arising from further information, e.g. monitoring data indicating potential 

P or B properties, needs to be considered in the assessment and the overall conclusion on the 

PBT or vPvB properties (see Section R.11.1.5 for further guidance). 

- 

9


10 

Table C.1-2: Screening criteria for Persistency, Bioaccumulation, and Toxicity 2 

Type of data Criterion Screening 

assignment 

Persistence 

Ready biodegradability test Readily biodegradable Not P and 

not vP 

Enhanced ready biodegradability test Readily biodegradable Not P and 

not vP 

Specified tests on inherent 

biodegradability 

Zahn-Wellens (OECD 302B) 

MITI II test (OECD 302C) 

Biowin 2 (non-linear model prediction) 

and Biowin 3 (ultimate biodegradation 

time) 

or 

Biowin 6 (MITI non-linear model 

prediction) and Biowin 3 (ultimate 

biodegradation time) 

Bioaccumulation 

Convincing evidence that a substance can 

biomagnify in the food chain (e.g. field 

data) 

Octanol-water partitioning coefficient 

(experimentally determined or estimated 

by QSAR) 

Toxicity 

≥ 70 % mineralisation (DOC removal) 

within 7 d; log phase no longer than 

3d; removal before degradation occurs 

below 15%; no pre-adapted inoculum 

≥ 70% mineralisation (O2 uptake) 

within 14 days; log phase no longer 

than 3d; no pre-adapted inoculum 

Does not biodegrade fast (probability 

Definitive assessment 


If, on the basis of the screening assessment, a substance is considered to potentially fulfil the 

criteria for P, B and T or for vP and vB, the registrant may choose to treat the substance as a 

PBT/vPvB-substance and report accordingly in the chemical safety report without further 

evaluation of the properties. 

If the registrant decides to further evaluate the properties of a substance that based on the 

screening assessment potentially fulfils the PBT or vPvB criteria, a definitive assessment of 

P/vP should be conducted first. Definitive assessment of P/vP should normally be based on 

half-life data collected under adequate conditions for the relevant compartment(s) of exposure 

(see Section C.1.4.1). 

If the substance is considered to fulfil the P and/or vP criterion, the PBT/vPvB assessment is 

continued by evaluation of the B/vB criterion. Definitive assessment of B/vB should normally 

be based on measured data on bioconcentration in aquatic species (see Section C.1.4.2). 

If the substance is not identified as vPvB but considered to fulfil the P and B criteria, the PBT 

assessment is continued by evaluation of the T criterion. Definitive assessment of T should be 

based on evaluation of the data for classification of the substance for human health hazards 

and/or on no-observed effect concentration(s)(NOECs) from long-term toxicity tests with 

aquatic organisms (see Section C.1.4.3). 

However, for substances for which persistency testing is difficult or practically impossible, 

like e.g. for certain multi-constituent or very poorly water soluble substances, it may 

sometimes be more reasonable to start the PBT/vPvB assessment by evaluating the B criterion 

(see Section R.11.1.3.2 for further guidance). 

C.1.4 Test strategies 

C.1.4.1 Persistency 

The detailed testing strategy on degradation for PBT/vPvB assessment is set out in Section 

R.11.1.3.1 and Figure R.11-1. It is based on a weight of evidence approach starting with the 

review of all available screening test data and non-test data ((Q)SAR model predictions, read 

across, and chemical categorisation). The criteria for the screening methods are given in Table 

C.1-2. In some cases, the performance of an enhanced ready biodegradation test may deliver 

sufficient information to draw the conclusion that the substance can be considered as "not P". 

If persistency cannot be excluded, it should be determined which compartments are likely to 

be exposed, and hence which simulation tests need to be conducted. This determination of the 

compartments(s) for simulation testing should take account of the intrinsic properties of the 

substance (e.g. water solubility, vapour pressure, log Kow, Kp, Koa, half-life in air) that are 

significantly influencing the environmental fate of the substance. Multi-media modelling (e.g. 

Mackay level 3 models) may also be used in order to determine the environmental 

compartment(s) of primary concern. 

Soil/sediment simulation degradation testing is warranted if the screening data indicate 

potential persistency and direct or indirect exposure of these compartments is likely. This 

includes cases where a substance is released to surface water but due to high sorption 

11


partitions to sediment or sewage sludge, which may be spread on soil, or where a substance is 

volatilised from water to air and deposited to soil. 

The Kp (sediment) may be used as an indicator of whether testing in a water-sediment system 

may be warranted. For example, it may be considered to conduct an aquatic sediment 

simulation test in addition to a pelagic simulation test for substances with Kp (sediment) > 

2000. 

C.1.4.2 Bioaccumulation 

A detailed test strategy for bioaccumulation testing for PBT/vPvB assessment is set out in 

Section R.11.1.3.2 and Figure R.11-2. In general, all existing information on the 

bioaccumulation potential of a substance should be collected and evaluated first before a 

decision on the necessity to conduct further testing is drawn. The existing data may include 

laboratory bioconcentration tests (aquatic, terrestrial and benthic) and field studies on 

biomagnification or bioaccumulation. Such available information might be sufficient to 

conclude whether the substance is vB, B, or not B (see Section R.11.1.3.2). 

If the above mentioned information is not available for a substance produced or imported at a 

level of less than 100 t/y and the substance has a log Kow ≤ 4.5 and no specific uptake 

mechanism apart from lipophilic partitioning is known or suspected, then the substance can be 

considered as not B and not vB and further evaluation of the B and vB criteria is not 

necessary. 

However, for a substance produced or imported at a level of 100 t/y or more, information on 

bioconcentration in aquatic species has to be made available by the registrant and to be 

considered in the assessment, unless this information can be waived according to column 2 of 

Annex IX or according to Annex XI(3) (e.g. low bioaccumulation potential, no exposure, 

testing technically not possible). 

In other cases, where: 

• no direct data on bioconcentration are available and the substance has a log Kow > 4.5, or 

the partitioning process into aquatic organisms is not driven by lipophilicity ; 

• direct data on bioconcentration are available but these data are not reliable and/or 

consistent to a degree sufficient to conclude whether the B or vB criteria are met; 

the B and vB properties should be evaluated in more detail. 

In this further evaluation, non-testing data should be used as indicators for limited 

bioaccumulation in a weight of evidence assessment together with supplementary information 

to examine whether the substance potentially meets the B and vB criteria. Because the 

indicators for limited bioaccumulation (e.g. molecular weight and size of the molecule, 

octanol solubility or log Kow) are on their own considered to be insufficient to abstain from 

confirmatory testing, the availability of other reliable information indicating a low 

bioaccumulation potential is essential. This supplementary information may comprise data 

showing no toxicity in a chronic toxicity study with mammals, no uptake in a toxicokinetic 

study, or it could be a bioconcentration study with invertebrates or reliable read-across from a 

structurally similar compound. Evidence of significant uptake of a substance in fish or 

mammals after prolonged exposure is a contraindication to using the above indicators of 

limited bioconcentration. 

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C.1.4.3 Toxicity 


A detailed test strategy for toxicity testing for PBT/vPvB assessment is set out in Section 

R.11.1.3.3 and Figure R.11-3. The strategy starts with the evaluation of the classification of 

the substance. If any classification criterion leading to the assignment of the R-phrases R45, 

R46, R48, R49, R60 – R63 is met, the substance fulfils the T criterion 3 and there is no need to 

perform any further aquatic studies for T assessment. 

When no such classification is assigned, data on aquatic toxicity should be evaluated. When 

no chronic toxicity data are available, a substance is considered to meet the T-criterion when 

an acute L/EC50 value from a standard toxicity (or reliable non-standard) test is < 0.01 mg/l. 

When the L/EC50 is < 0.1 mg/l, the substance is considered to meet potentially the Tcriterion, 

and consequently the substance is referred to definitive T testing and chronic studies 

are required (regardless of the tonnage band). Note however that, due to animal welfare 

concerns, the general scheme of testing and confirming first P and B should be applied before 

further T-testing is considered. Also, vertebrate-animal testing should be minimised by first 

testing non-vertebrate species. Normally, the testing order for conclusion on T based on 

chronic data is Daphnia and then fish 4 , unless there is evidence that fish are more sensitive 

than daphnia. If the T-criterion is fulfilled by the chronic algae or Daphnia data, a chronic fish 

test is not necessary. If however a long term test on Daphnia or algae provides a NOEC close 

to but above 0.01 mg/l, a long-term fish study is likely to be needed to confirm “not T”. 

For certain lipophilic substances (with a log Kow >5) acute toxicity may not occur at the limit 

of the water solubility of the substance tested (or the highest concentration tested). In such 

situations, chronic toxicity with a NOEC 0.1 mg/l, because these substances may not 

have had sufficient time in the acute test to be significantly taken up by the test organisms and 

to reach equilibrium partitioning. (see Section R.11.1.3.3, ITS for T-testing, Figure R.11-3 

and decision tree Steps 2, 5 & 6). 

In the absence of definitive information on T, for substances with very high lipophilicity, a 

weight of evidence or group approach for long term toxicity may be used to predict whether 

long term effects are likely to occur. If convincing evidence is available that aquatic toxicity 

is not expected to occur at


C.1.5 Conclusions on PBT or vPvB properties 

A detailed analysis of the persistence, bioaccumulation and toxicity should be brought 

together into a clear conclusion on whether the substance should be treated as a PBT/vPvB 

substance. There are a number of conclusions from this comparison that call for different 

responses from a registrant (see Section R.11.1.5 for further guidance). 

(i) The data show that the properties of the substance meet the specific criteria detailed in 

Annex XIII, or do not allow a direct comparison with all the criteria in Annex XIII, but 

nevertheless indicate that the substance would have these properties 

In this case an emission and risk characterisation for PBT/vPvB substances in accordance 

with the stipulations of Annex I is required. 

(ii) The data show that the properties of the substance do not meet the specific criteria 

detailed in Annex XIII or do not allow a direct comparison with all the criteria in Annex 

XIII but nevertheless indicate that the substance would not have these properties and the 

substance is not considered a PBT/vPvB 

In this case the PBT/vPvB assessment stops at this point. An exposure assessment and 

risk characterisation as for a non-PBT/vPvB substance may however be required if the 

substance is dangerous in accordance with the classification criteria of Council Directive 

67/548/EEC. 

(iii) The data on the properties of the substance do not allow a direct comparison with all the 

criteria in Annex XIII and further information is needed 

In this case a registrant has two options: 

• The registrant generates the required information (depending on the information 

needed, the submission of a testing proposal may be required) and concludes on the 

PBT/vPvB properties of the substance concerned once the lacking data are available 

(i.e. conclusion (i) or (ii)); or 

• The registrant refrains from generating further information and treats his substances as 

if it were a PBT/vPvB. 

(iv) Further information would be needed to conclude on the PBT/vPvB properties of the 

substance. However, the registrant (for several reasons) has decided not to conduct 

confirmatory testing. 

If a clear decision on the properties of a substance cannot be made, either because it is 

not possible to characterise a substance, or since it is technically not possible to conduct 

testing, this lack of a clear decision does not obviate the requirement on a registrant to 

propose appropriate and proportionate RMMs and OCs. 

C.1.6 Further actions if a substance is identified as a PBT or a vPvB 

If it is concluded that the substance is a PBT or vPvB substance, or that it should be treated as 

such, the registrant must conduct an emission characterisation and a risk characterisation for 

PBT/vPvB substances in accordance with Article 14 (4). 

Generally, if a substance contains one or more constituents with PBT/vPvB properties in 

individual amounts ≥ 0.1 % (w/w) or if transformation/degradation products with the 

respective properties in amounts ≥ 0.1 % are being generated, the substance must be subjected 

14


to PBT/vPvB specific emission characterisation and risk characterisation. However, for the 

sake of relevance of risk exerted by the amount of a PBT/vPvB substance 

manufactured/imported by a registrant, and hence with regard to the requirements for risk 

characterisation and nature of RMM to be implemented, it may be considered to use a 

threshold value of 10% (w/w) for the total of all constituents or transformation/degradation 

products having PBT or vPvB properties, if it is possible to estimate with sufficient certainty 

that the total manufacture/import or supply of PBT/vPvB constituents in that substance and 

the total amount of degradation/transformation products with PBT/vPvB properties generated 

by that substance do not exceed 1 t/y 5 . In the considerations as to whether application of this 

percentage trigger could be appropriate, the use pattern of the substance and the potential 

emissions of the constituents or transformation/degradation products having PBT or vPvB 

properties must be accounted for. 

The main objective of the emission characterisation is to estimate the amounts of the 

substance released to the different environmental compartments and to identify the likely 

routes by which humans and the environment are exposed to the substance. A registrant has 

only to take care of his own tonnage 6 . In co-operation with his downstream users he has to 

cover, where relevant, any manufacture in the EU he is responsible for, his own uses and all 

identified uses including all resulting lifecycle stages. 

The principal tool to achieve this objective is exposure scenarios (ES(s)). Part D and Chapters 

R.12 to R.18 provide guidance on how to develop ESs for substances in general. Parts of the 

exposure assessment guidance are relevant also for PBT/vPvB substances (i.e. emission 

estimation and assessment of chemical fate and pathways). However, since the objectives are 

not the same the general scheme for exposure assessment needs to be adapted to the 

requirements of emission characterisation for PBT/vPvB substances. Below guidance is given 

on some issues where special considerations are needed for PBT/ vPvB substances. In the 

context of the emission characterisation, the registrant needs to develop ES(s) for all 

identified uses of his PBT/vPvB substance, unless he concludes to advise in his technical 

dossier (and SDS) against certain uses of his substance. In this latter case he does not need to 

perform an emission characterisation or other risk management work related to these uses. 

As PBTs and vPvBs are substances of very high concern, the registrant shall pay special 

attention to the level of detail of his assessment and whether its accuracy and reliability is 

sufficient for a PBT/vPvB substance. Where generic scenarios and assumptions may be 

sufficient for exposure assessment of non PBT/vPvB-substances, specific scenarios and data 

will most likely be needed throughout an emission characterisation for PBT/vPvB-substances. 

All effort necessary should be made to acquire for manufacture and any identified use 

throughout the lifecycle, site- and product-specific information on emissions and likely routes 

by which humans and the environment are exposed to the substance. The emission 

5 Please note that the proposed one tonne per year threshold for the total of compounds with PBT/vPvB properties in a 

substance consisting of more than one component (be it a preparation or a multi-constituent substance) is not an 

‘allowable release’ threshold. It refers instead to the content in a substance that will need to have appropriate risk 

assessment and management justified in the chemical safety report. 1 t/y is the level at which the registration 

requirement under REACH normally begins to apply if a substance was supplied alone or in a preparation. 1 t/y is 

also the trigger for registration in an article. Therefore, this amount is considered to be a suitable threshold level for 

relevance and hence adaptation of required risk assessment efforts and, depending on the results of risk assessment, 

possibly risk management measures. 

6 However, it can be useful to consider on a voluntary basis exposure resulting from emissions of the same substance 

manufactured or imported by other registrants (i.e., the overall estimated market volume), c.f. Part A.2.1. 

15


characterisation shall in particular be specific in the use description and concerning RMMs, 

and shall furthermore contain an estimation of the release rate (e.g. kg/year) to the different 

environmental compartments during all activities carried out during manufacture or identified 

uses (see Section R.11.2.1 for further guidance). 

The objective of a risk characterisation for substances satisfying the PBT or vPvB criteria is to 

use the information obtained in the emission characterisation step to implement on a 

registrant's site or to recommend to his downstream users RMMs which minimise exposures 

and emissions to humans and the environment throughout the lifecycle of the substance that 

results from manufacture or identified uses (Annex I (6.5)). To this end, the minimisation of 

exposures and emissions to humans and the environment needs to be considered throughout 

the development of ES(s). The need or a potential to (further) minimise emissions or exposure 

may therefore be recognised at any point in the development of an ES. In this way, the 

appropriateness and effectiveness of RMMs and OCs should be assessed in the development 

of the ES. 

Suitable options and measures to minimise emissions of and exposure to a PBT/vPvB 

substance are, for instance, substitution of the substance or reduction of its use when 

technically possible, manufacture and use under strictly controlled conditions and handling of 

the substance by trained personal only (see Section R.11.2.2 for further guidance). 

The final ES, or ES(s) in case of different uses, shall be presented under the relevant heading 

of the chemical safety report, and included in an annex to the SDS. It shall describe the 

required OCs and RMMs in a way that downstream users can check whether they have to 

implement any measures in order to minimise emissions or exposures of humans and the 

environment. 

16

PBT Assessment - REACh

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